Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707

A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 12/16/20 was sent to customers. Action to be Taken: As a precautionary measure, we recommend that users perform two in-house checks prior to using a new flask to improve detection of the manufacturing defect. 1. Visual Inspection Check the flask assembly: when the stopper is placed on the flask, the tab on the silicone stopper should engage with the indent in the flask. Flasks that have the defect may not allow the stopper to be fully pushed into the indent of flasks, as shown in Figure 1. 2. Leak Test Check for leaks: Flasks that have the defect will cause a gas leak that will impede gas flow into the Mini Incubator. a. Prepare the Mini Incubator by removing any flasks. b. Fill the flask to be tested with sterile distilled water (to the fill line) and insert it into the incubator. c. Set the flow rate to 15mL/min and wait for the purge cycle to complete. d. Block the gas flow from both tubes exiting the flask by kinking and holding the tubes as shown in Figure 2. i. When the tubes are folded, the area around the folds may appear white this does not indicate that the silicone tubing has been damaged. e. If the gas flow does not fall to zero within 45 seconds, the flask may be defective. f. Unblock the tubes as soon as the flow reaches zero; blocking the tubes for more than two minutes may cause pressure to build up in the flask and the silicone stopper to suddenly pop off. i. Gas flow may be greater than 15mL/min immediately after the tubes are unblocked. This is normal the incubator will gradually adjust the gas flow rate to the correct value. g. If a potential defect is discovered, please take a photo and report this to Cook Medical Customer Relations, [email protected] or 1-800-4574500, extension 152146, referencing FAIP 2020-0006 , in order to obtain a credit for the faulty product. Do not use the flask if a potential defect is discovered. Dispose of